Lead Regulatory Specialist

Job Summary

A company is looking for a Lead Regulatory Specialist- Medical Device.

Key Responsibilities

• Lead regulatory documentation review and release for prescription Medical Device products
• Support the compilation and submission of drug substance regulatory dossiers for the Biopharma team
• Collaborate cross-departmentally to ensure compliance with regulatory requirements and support product classification

Required Qualifications

• Bachelor's Degree in a relevant field (Biology, Pharmacy, Chemistry, etc.)
• Minimum of 2 years of experience in a regulated industry (pharmaceutical or medical device)
• Experience with ICH Q7, IPEC, and/or 21 CFR 820
• Knowledge of state and federal regulations for Prescription Medical Devices and Cell and Gene Therapy
• Experience with project management and development of SOPs and best practices